Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and DNAtrix today announced they have entered into an
oncology clinical study collaboration to evaluate the efficacy and
safety of DNX-2401, DNAtrix’s oncolytic immunotherapy, in
combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1
therapy, in a Phase 2, multi-centered study of patients with
recurrent glioblastoma, the most aggressive form of brain cancer
for which there is no cure.
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DNX-2401 is a conditionally replicative oncolytic adenovirus
designed to specifically target cells defective in the
Retinoblastoma (Rb) pathway, which is present in many cancers.
Several DNX-2401 clinical studies have demonstrated a favorable
safety profile and strong tumor-killing potential in patients with
recurrent glioblastoma. KEYTRUDA is a humanized monoclonal antibody
that blocks the interaction between PD-1 (programmed death
receptor-1) and its ligands, PD-L1 and PD-L2. KEYTRUDA is currently
approved in the United States for certain types of advanced
metastatic melanoma.
“We are excited to enter into this important collaboration with
Merck as we investigate the potential anti-tumor effect that
combining our two immunotherapies – DNX-2401 and KEYTRUDA – may
offer patients with this aggressive disease,” said Frank Tufaro,
Ph.D., chief executive officer of DNAtrix.
“The collaboration with DNAtrix further strengthens our efforts
to progress the field of immuno-oncology and identify potential
combinations that will significantly advance the care of people
with cancers for which there have been few advancements,” said Dr.
Eric Rubin, vice president and therapeutic area head, oncology
early-stage development, Merck Research Laboratories. “We look
forward to studying the potential synergistic effects that
combining DNX-2401 and KEYTRUDA could have in the treatment of
patients with recurrent glioblastoma.”
The agreement is between DNAtrix and Merck, through a
subsidiary. Additional details of the collaboration were not
disclosed.
About Glioblastoma
Glioblastoma is a type of glioma, which are tumors that arise
from glial cells, or supportive brain cells that help to keep
neurons in place and functioning well. Glioblastoma is highly
malignant because the cells reproduce quickly and are supported by
a large network of blood vessels. While glioblastoma rarely spreads
elsewhere in the body, these tumors arise from normal brain cells,
so it is easy for them to invade and live within normal brain
tissue. Glioblastoma represents 17 percent of all primary brain
tumors and 54 percent of all gliomas.
About DNX-2401
DNX-2401 is an investigational oncolytic immunotherapy designed
to treat high grade gliomas. Upon tumor injection, DNX-2401 sets
off a chain reaction of tumor cell killing by selectively
replicating within glioma cells (but not normal cells), causing
tumor destruction and further spread of the oncolytic virus to
adjacent tumor cells. This process can also trigger an anti-tumor
immune response. DNX-2401 is currently being investigated in
several clinical studies and has been well tolerated in all
settings. Compelling results from Phase I clinical studies in
recurrent glioblastoma indicate that DNX-2401 can (1) replicate in
human brain tumors for a period of weeks to months (2) trigger
immune cell infiltration into the tumor (3) cause ongoing tumor
destruction detectable by MRI and (4) induce durable responses to
therapy. In these studies, patient survival has been prolonged in a
subset of patients, including in those achieving a complete
response.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that blocks the
interaction between PD-1 and its ligands, PD-L1 and PD-L2. By
binding to the PD-1 receptor and blocking the interaction with the
receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated
inhibition of the immune response, including the anti-tumor immune
response. KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma and disease progression
following ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor. This indication is approved under accelerated approval
based on tumor response rate and durability of response. An
improvement in survival or disease-related symptoms has not yet
been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients, including
Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively,
receiving KEYTRUDA. Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic
imaging. Administer corticosteroids for Grade 2 or greater
pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving KEYTRUDA. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3;
permanently discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%)
of 411 patients, including a Grade 4 case in 1 (0.2%) patient,
receiving KEYTRUDA. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a
Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient,
receiving KEYTRUDA. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids for Grade 2 or greater hypophysitis.
Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3;
and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including
Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively,
receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411
patients, including a Grade 3 case in 1 (0.2%) patient, receiving
KEYTRUDA. Thyroid disorders can occur at any time during treatment.
Monitor patients for changes in thyroid function (at the start of
treatment, periodically during treatment, and as indicated based on
clinical evaluation) and for clinical signs and symptoms of thyroid
disorders. Administer corticosteroids for Grade 3 or greater
hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently
discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated
hypothyroidism may be managed with replacement therapy without
treatment interruption and without corticosteroids.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving KEYTRUDA. Monitor patients for
hyperglycemia and other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA in cases of
severe hyperglycemia until metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients, consisting of one case
of Grade 2 autoimmune nephritis (0.2%) and two cases of
interstitial nephritis with renal failure (0.5%), one Grade 3 and
one Grade 4. Monitor patients for changes in renal function.
Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for
Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can
occur. The following clinically significant immune-mediated adverse
reactions occurred in patients treated with KEYTRUDA: exfoliative
dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic
anemia, partial seizures arising in a patient with inflammatory
foci in brain parenchyma, severe dermatitis including bullous
pemphigoid, myasthenic syndrome, optic neuritis, and
rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on
the severity of the adverse reaction, withhold KEYTRUDA and
administer corticosteroids. Upon improvement of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Restart KEYTRUDA if the
adverse reaction remains at Grade 1 or less. Permanently
discontinue KEYTRUDA for any severe or Grade 3 immune-mediated
adverse reaction that recurs and for any life-threatening
immune-mediated adverse reaction.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
KEYTRUDA. Monitor patients for signs and symptoms of
infusion-related reactions including rigors, chills, wheezing,
pruritus, flushing, rash, hypotension, hypoxemia, and fever. For
severe or life-threatening reactions, stop infusion and permanently
discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA may cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
KEYTRUDA was discontinued for adverse reactions in 9% of 411
patients. Adverse reactions, reported in at least two patients,
that led to discontinuation of KEYTRUDA were: pneumonitis, renal
failure, and pain. Serious adverse reactions occurred in 36% of
patients. The most frequent serious adverse reactions, reported in
2% or more of patients, were renal failure, dyspnea, pneumonia, and
cellulitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (47%), cough (30%), nausea (30%), pruritus
(30%), rash (29%), decreased appetite (26%), constipation (21%),
arthralgia (20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until
disease progression or unacceptable toxicity. No formal
pharmacokinetic drug interaction studies have been conducted with
KEYTRUDA. It is not known whether KEYTRUDA is excreted in human
milk. Because many drugs are excreted in human milk, instruct women
to discontinue nursing during treatment with KEYTRUDA. Safety and
effectiveness of KEYTRUDA have not been established in pediatric
patients.
About DNAtrix
DNAtrix is a privately held, clinical stage, biotechnology
company developing virus-driven immunotherapies for
cancer. DNAtrix’s lead product, DNX-2401, is a conditionally
replicative oncolytic virus being studied in clinical trials for
recurrent glioblastoma, an incurable brain cancer. The company
is backed by Morningside Ventures and Mercury Fund, and has been
awarded a grant from the Cancer Prevention and Research Institute
of Texas (CPRIT). For more information, please visit the company
website at http://www.dnatrix.com.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our
focus is on pursuing research in immuno-oncology and we are
accelerating every step in the journey – from lab to clinic – to
potentially bring new hope to people with cancer. For more
information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA
(the “company”) includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include, but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and healthcare
legislation in the United States and internationally; global trends
toward healthcare cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2014
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA
(pembrolizumab) at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
and the Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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version on businesswire.com: http://www.businesswire.com/news/home/20151001005478/en/
MerckMedia Relations:Pamela Eisele, 267-305-3558orAn
Phan, 908-255-6325Investor Relations:Teri Loxam, 908-740-1986Justin
Holko, 908-740-1879orDNAtrixInvestor/Media Relations:Imran
Alibhai, Ph.D.ialibhai@dnatrix.com
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